RecruitingPhase 4NCT05444699

Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age

Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age: a Point-of-care Testing Guided Randomized, Double-blind, Placebo-controlled Trial


Sponsor

University of Oulu

Enrollment

210 participants

Start Date

Oct 11, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of the trial is to evaluate whether the use of oral prednisolone directed by point-of-care testing is useful in acute wheezing caused by rhinovirus in children aged 6-24 months.


Eligibility

Min Age: 6 MonthsMax Age: 24 Months

Inclusion Criteria3

  • Wheezing bronchitis diagnosed by a physician
  • Need for salbutamol treatment at the emergency department
  • Positive nasopharyngeal rhinovirus or picornavirus finding in point-of-care testing

Exclusion Criteria15

  • Need for immediate resuscitation
  • Immediate transfer to ICU
  • Suspected pneumonia based on the auscultation finding
  • Suspected serious bacterial infection
  • Other respiratory virus finding in the absence of rhinovirus or picornavirus
  • Positive respiratory syncytial virus finding
  • Positive SARS-coronavirus-2 finding
  • Positive Mycoplasma pneumoniae finding
  • Positive Bordetella pertussis finding
  • Contact with a person with chickenpox within 14 days
  • Active chickenpox
  • Suspected foreign body of the respiratory tract
  • Immunosuppressive treatment
  • Systemic corticosteroid treatment within 14 days
  • Allergy to corticosteroids

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Interventions

DRUGPrednisolone Sodium Phosphate

Oral suspension administered 1 mg/kg once a day for three days

DRUGSugar syrup

Oral suspension administered the same amount in milliliters as experimental product once a day for three days


Locations(2)

SOITE Lastenpäivystys

Kokkola, Finland

OYS Lastenpäivystys

Oulu, Finland

View Full Details on ClinicalTrials.gov

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NCT05444699